Postdoctoral Fellowship in Regulatory Science

Overview

In the past decade, a plethora of new healthcare products have been developed, including innovative drugs for rare diseases, genome and cell based therapies, mobile health products and implantable devices. Corresponding to the surge in these innovative products, there has been a scarcity of well-trained individuals to expertly evaluate them for safe and effective use. In fact, regulatory agencies such as the FDA as well as medical product developers have a shortage of highly trained individuals with knowledge of a broad spectrum of regulatory sciences. The educational mission of the Center of Excellence in Regulatory Science and Innovation, co-led by UC San Francisco and Stanford University (UCSF-Stanford CERSI), is to train a new generation of scientists by providing opportunities to broaden their knowledge about tools, methods, and standards to support regulatory science and medical product development.

The UCSF-Stanford CERSI postdoctoral fellowship is an experiential program that will provide our most outstanding postdocs with unique immersion experiences in regulatory science research. Support for the fellowship program will be provided by both financial and in-kind contributions from UCSF-Stanford CERSI Industrial Affiliates and Board members, by institutional funds (including gifts) from UCSF and Stanford, and, when funds are available, by the FDA.

Our objective is that each fellow should have a sufficient foundation and breadth in their training to engage in and serve as an ambassador for regulatory science research and education. During the program, Fellows will receive a monthly stipend commensurate with education level and experience. The Fellows will spend the first year at UCSF or Stanford, and in years 2-3, when projects are available, Fellows have an opportunity to train with industry and/or FDA. The fellowship components are:

Regulatory Science Research and Training (1 year)

Fellows will be actively involved in research programs prior to their nomination and during the first year of their fellowship. During the first year, fellows are expected to spend at least 90% of their time on their research projects. The research projects will either extend existing regulatory science projects or will be entirely new one-year projects. In addition to research, Fellows will be expected to complete courses focusing on regulatory science and actively participate in scientific seminars and symposia. In addition, Fellows will take part in regularly scheduled networking and mentoring events.

Immersion Experience in Industry (6-12 months)

Each Fellow will be assigned a mentor and will work alongside clinicians, engineers, and other scientists. Fellows will either continue their academic regulatory science projects or will be assigned an entirely new project. Fellows will either continue their academic research projects or will be involved in an on-going research project. Research projects will be discussed with Fellows during their first year. Fellows will be required to attend an annual symposium at UCSF or Stanford.

Immersion Experience at FDA (6-12 months)

Each Fellow will be paired with a mentor and will work alongside clinicians, engineers, or other scientists in regulatory science research. Fellows will either continue their academic research projects or will be involved in an on-going research project. Research projects will be discussed with Fellows during their first year. The Fellows will have an opportunity to attend seminars and workshops held at the FDA giving them the opportunity to learn about different aspects of regulatory science. Fellows will be required to attend an annual symposium at UCSF or Stanford.

Statement of Completion and Employment

Fellows will receive a terminal document certifying their participation in the fellowship program upon completion of all fellowship components. Immersive experiences in industry and at the FDA do not guarantee job placements.

Eligibility criteria

Applicants must hold a PhD-level degree in biological or biomedical sciences, bioengineering or a related field, be a U.S. citizen or permanent resident of the United States, and have an excellent record of achievement. Applicants cannot be current FDA employees, contractors, or fellows.

Application Process

The following materials are required for a completed proposal by March 1, 2017:

Statement of Interest (1,000 word maximum) describing the candidate’s background and qualifications, regulatory science interests, skills to be acquired, and career goals, including how the fellowship would support those goals